[Federal Register Volume 61, Number 191 (Tuesday, October 1, 1996)]
[Notices]
[Pages 51285-51287]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-25076]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 96N-0192]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995, 
Federal agencies are required to publish a notice in the Federal 
Register concerning each proposed collection of information and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on a new harmonized application form, Application to 
Market a New Drug, Biologic, or an Antibiotic Drug for Human Use, Form 
FDA 356h. This form will apply to a wide range of products for human 
use that are regulated by both the Center for Drug Evaluation and 
Research (CDER) and the Center for Biologics Evaluation and Research 
(CBER), including drugs, biologics, and antibiotics. The form will 
replace a number of different application forms that are now used for 
these products.

DATES: Submit written comments on the collection of information by 
December 2, 1996.

ADDRESSES: 
    CDER Information: Submit written requests for single copies of the 
new harmonized application form, Form FDA 356h, to the Drug Information 
Branch (HFD-210), Division of Communications Management, Center for 
Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-1012. Send one self-
addressed adhesive label to assist that office in processing your 
requests. The form may also be obtained by calling the CDER FAX-ON-
DEMAND System at 1-800-342-2722 or 1-301-827-0577.
    CBER Information: Submit written requests for single copies of the 
new harmonized application form, Form FDA 356h, to the Division of 
Congressional and Public Affairs (HFM-44), Center for Biologics and 
Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, 
MD 20852-1448. Send one self-addressed adhesive label to assist that 
office in

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processing your requests. The form may also be obtained by FAX by 
calling the CBER Voice Information System at 1-800-835-4709.
    Submit written comments on the new harmonized application form, 
Form FDA 356h, and its proposed use in the collection of information, 
to the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. Two 
copies of any comments are to be submitted except that individuals may 
submit one copy. Requests and comments should be identified with the 
docket number found in brackets in the heading of this document. A copy 
of the new harmonized application form, Form FDA 356h, and received 
comments are available for public examination in the Dockets Management 
Branch between 9 a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1686.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)) requires Federal 
agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information. ``Collection of information'' 
is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c). To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information listed below.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

Application to Market a New Drug, Biologic, or an Antibiotic Drug 
for Human Use; Use of Form FDA 356h

    FDA is the Federal agency charged with responsibility for 
determining that drugs, including antibiotic drugs, and biologics are 
safe and effective. Manufacturers of a drug, biologic, or an antibiotic 
drug for human use must file applications for FDA approval of the 
product prior to introducing it into interstate commerce. Statutory 
authority for the collection of this information is provided by 
sections 505(a), (b), and (j) and 507 of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 355(a), (b), and (j) and 357) and 
section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262). 
All manufacturers of new drugs and antibiotics for human use regulated 
under the act must submit an application for review and approval to 
CDER or CBER prior to marketing a drug or antibiotic in interstate 
commerce (21 CFR 314.50). All manufacturers of generic drugs, including 
generic antibiotic drugs for human use, regulated under the act must 
submit an abbreviated new drug application (ANDA) or an abbreviated 
antibiotic drug application (AADA) for review and approval to CDER 
prior to marketing a generic drug in interstate commerce (21 CFR 
314.94). Most manufacturers of biological products regulated under the 
PHS Act must submit an establishment license application and a product 
license application for review and approval to CBER prior to marketing 
a biological product in interstate commerce (21 CFR 601.2). Blood and 
blood components fall within the category of biological products. All 
establishments collecting and/or preparing blood and blood components 
for sale or distribution in interstate commerce are subject to the 
licensing application provisions of section 351 of the PHS Act. 
Manufacturers of a drug, biologic, or an antibiotic drug for human use 
are required to file supplemental applications for all important 
changes to applications previously approved prior to implementing such 
changes (21 CFR 314.70, 314.71, 314.97, and 601.12).
    Form FDA 356h has been revised for CDER-regulated products to 
include identification of different types of supplemental applications. 
It has also been modified to include a section for establishment 
information pertaining to CBER-regulated products and the CBER 
licensing process.
    The information provided by manufacturers with the revised 
application form is necessary for FDA to carry out its mission of 
protecting the public health and helping to ensure that drugs, 
biologics, and antibiotics for human use have been shown to be safe and 
effective. Form FDA 356h was developed initially as a checklist to 
assist manufacturers in filing a drug application and has been 
previously used only by manufacturers of products regulated under the 
act. The revised form has been harmonized for use by manufacturers of 
products regulated under the act or under the PHS Act and will be used 
by industry regulated by both CDER and CBER. The harmonized application 
form serves primarily as a checklist for firms to gather and submit to 
the agency studies and data that have been completed. The checklist 
helps to ensure that the application is complete and contains all the 
necessary information, so that delays due to lack of information may be 
eliminated. The form will also provide key information to the agency 
for efficient handling and distribution to the appropriate staff for 
review. The revised form will replace a number of different application 
forms that are now used for these products and is intended to help 
harmonize the application process.
    FDA estimates the burden of this collection of information as 
follows:
    There are no capital costs or operating and maintenance costs 
associated with this collection.

                                   Table 1.--Estimated Annual Reporting Burden                                  
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                                                      Annual                                                    
       Type of Response\1\            No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                  Respondents\2\    Response\3\    Responses\4\      Response                   
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NDA \5\                               162              22.9         3,715              40         148,600       
ANDA \6\ and AADA \7\                 350              18.6         6,517              40         260,680       
ELA \8\ and PLA \9\                   391               4.9         1,905              40          76,200       
Total Burden Hours                                                                                485,480       
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\1\ Includes original applications and their amendments and supplemental applications                           
\2\ Number of sponsors submitting applications during fiscal year (FY) 95                                       
\3\ Average number of applications submitted per sponsor                                                        

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\4\ Total applications submitted during FY 95                                                                   
\5\ New Drug Application (includes applications for new antibiotic drugs)                                       
\6\ Abbreviated New Drug Application                                                                            
\7\ Abbreviated Antibiotic Drug Application                                                                     
\8\ Establishment License Application                                                                           
\9\ Product License Application                                                                                 

    In FY 95, CDER received a total of 10,232 submissions and CBER 
received 1,905 submissions that would require use of this application 
form. FDA estimates that 40 hours would be required for an industry 
regulatory affairs specialist to fill out the harmonized form, collate 
the documentation, and submit the application to CDER or CBER.

    Dated: September 25, 1996.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 96-25076 Filed 9-30-96; 8:45 am]
BILLING CODE 4160-01-F